NCT06323161CompletedPhase 3
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4 mg/2.4 mg and 1.0 mg/1.0 mg Once Weekly Versus Placebo in Participants With Type 2 Diabetes as Add on to Once-daily Basal Insulin With or Without Metformin
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
This study will look at how much CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participant will get either CagriSema or "dummy" medicine and which treatment they get is decided by chance. Participant will take the study medicine together with their current diabetes medicine (once-daily insulin with or without metformin). For each participant, the study will last for about one year.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 274 (actual)
- First submitted
- 15 Mar 2024
- Start date
- 26 Mar 2024
- Primary completion date
- 9 Sept 2025
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 2 diabetes
- NCT number
- NCT06323161
- EU CT number
- 2022-502679-43-00
- EudraCT number
- 2022-502679-43
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 274
- From 26 Mar 2024 to the primary completion date, 9 Sept 2025
- 61 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Lab values
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening.
Other
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
- Known hypoglycaemia unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
- Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
Who the study is looking for
- Male or female (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
- Diagnosed with type 2 diabetes mellitus ≥180 days before screening.
- On stable once-daily dose of basal insulin (minimum of 0.25 units per kilogram per day (U/kg/day) or 20 U/day) alone or in combination with metformin (at effective or maximum tolerated dose as judged by the investigator) for 90 days prior to screening.
- Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening.
- Body Mass Index (BMI) greater than or equal to 25 kilogram per square meter (kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (61)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese People's Liberation Army General Hospital-Endocrinology Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Ji'nan | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Huaihe Hospital of Henan University Coordinator of this site? Confirm its status | Kaifeng | China | Unknown status |
| Huaihe Hospital of Henan University-Endocrinology Coordinator of this site? Confirm its status | Kaifeng | China | Unknown status |
| The Second Affiliated Hospital of Nanjing Medical University-Endocrinology Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The Second Affiliated Hospital of Nanjing Medical University_Nanjing Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Shanghai Pudong New Area People's Hospital-Endocrinology Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The Affiliated Hospital of Jiangsu University-Endocrinology Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
| Kumanomae Nishimura Naika Clinic_Internal Medicine Coordinator of this site? Confirm its status | Arakawa-ku, Tokyo | Japan | Unknown status |
| Akaicho Clinic Coordinator of this site? Confirm its status | Chiba-shi, Chiba | Japan | Unknown status |
| Kunisaki Makoto Clinic Coordinator of this site? Confirm its status | Fukuoka-shi, Fukuoka | Japan | Unknown status |
| Futata Tetsuhiro Clinic Meinohama_Internal medicine Coordinator of this site? Confirm its status | Fukuoka-shi, Fukuoka | Japan | Unknown status |
| Sasaki Internal Medicine Coordinator of this site? Confirm its status | Hokkaido | Japan | Unknown status |
| Naka Kinen Clinic_Internal medicine Coordinator of this site? Confirm its status | Ibaraki | Japan | Unknown status |
| H.E.C Science Clinic Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| H.E.C Science Clinic_Internal Medicine, Diabetes Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| Kyoto University Hospital_Department of Diabetes, Endocr Coordinator of this site? Confirm its status | Kyoto-shi, Kyoto | Japan | Unknown status |
| Minami Akatsuka Clinic_internal medicine Coordinator of this site? Confirm its status | Mito-shi, Ibaraki | Japan | Unknown status |
| Manda Memorial Hospital_Internal Medicine Coordinator of this site? Confirm its status | Sapporo-shi, Hokkaido | Japan | Unknown status |
| Tokyo-Eki Center-building Clinic_Internal Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Fukuwa Clinic_Internal Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Tokyo-Eki Center-building Clinic Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Kato Clinic of Internal Medicine_Internal Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Tsuruma Kaneshiro Diabetes Clinic_Internal medicine Coordinator of this site? Confirm its status | Yamato-shi | Japan | Unknown status |
| Healthcare centre Zvezdara Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Healthcare centre Kragujevac Coordinator of this site? Confirm its status | Kragujevac | Serbia | Unknown status |
| Healthcare centre Nis Coordinator of this site? Confirm its status | Niš | Serbia | Unknown status |
| University Clinical Centre Nis Coordinator of this site? Confirm its status | Niš | Serbia | Unknown status |
| Policlinic for diabetes Coordinator of this site? Confirm its status | Zaječar | Serbia | Unknown status |
| Dia Kontrol s.r.o. Coordinator of this site? Confirm its status | Kalna Nad Hronom | Slovakia | Completed |
| MOMED, s.r.o Coordinator of this site? Confirm its status | Kráľovský Chlmec | Slovakia | Completed |
| SIN AZUCAR s.r.o. Coordinator of this site? Confirm its status | Malacky | Slovakia | Completed |
| ENRIN, s.r.o. Coordinator of this site? Confirm its status | Rimavská Sobota | Slovakia | Completed |
| LUDIA, s. r. o. Coordinator of this site? Confirm its status | Spišská Nová Ves | Slovakia | Completed |
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Velocity Clinical Res-Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Elite Research Center Coordinator of this site? Confirm its status | Flint | United States | Unknown status |
| Valley Research Coordinator of this site? Confirm its status | Fresno | United States | Unknown status |
| Synergy Groups Medical Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| PlanIt Research, PLLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Holston Medical Group. Coordinator of this site? Confirm its status | Kingsport | United States | Unknown status |
| Palm Research Center Inc Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Manassas Clinical Research Center Coordinator of this site? Confirm its status | Manassas | United States | Unknown status |
| Solaris Clinical Research Coordinator of this site? Confirm its status | Meridian | United States | Unknown status |
| Bioclinical Research Alliance Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Clinical Research Associates Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| TPMG Clinical Research Coordinator of this site? Confirm its status | Newport News | United States | Unknown status |
| Alliance for Multispec Res Coordinator of this site? Confirm its status | Newton | United States | Unknown status |
| Valley Clinical Trials, Inc. Coordinator of this site? Confirm its status | Northridge | United States | Unknown status |
| Endo and Metab Consultants Coordinator of this site? Confirm its status | Rockville | United States | Unknown status |
| Simcare Medical Research, LLC Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| Iowa Diab & Endo Res Center Coordinator of this site? Confirm its status | West Des Moines | United States | Unknown status |
| Oraderumaz (Pty) Ltd Coordinator of this site? Confirm its status | Bloemfontein | South Africa | Unknown status |
| Ashmed Medi-Centre Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Dr Vawda's site Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| Hemant Makan Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Lenasia Clinical Trial Centre Coordinator of this site? Confirm its status | Lenasia | South Africa | Unknown status |
| Prinshof Medical Campus Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
| Clinical Trial Systems (CTC) Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
| Dr Noeth's Practice Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.